NCT01037205

Randomized, Double-blind, Placebo Controlled Phase II Study to Examine the Effects of DAS181 in Healthy Adult Subjects With Laboratory Confirmed Influenza

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 264 (actual)
• Sponsor: Ansun Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This protocol will seek to enroll adult otherwise healthy subjects presenting with influenza-like illness (ILI). Subjects will enter the study based on listed inclusion/exclusion criteria, including a positive diagnostic test for influenza virus (IFV).

Detailed description

This protocol will seek to enroll adult otherwise healthy subjects presenting with influenza-like illness (ILI). Subjects will enter the study based on listed inclusion/exclusion criteria, including a positive diagnostic test for influenza virus (IFV). Based upon a Rapid Diagnostic Test of IFV, subjects will be randomized into one of three groups: a single dose DAS181 10 mg group, a multiple dose DAS181 10 mg, 10 mg, 10 mg dose group or a placebo group. The full analysis set will include subjects with confirmed influenza as documented with Rapid Diagnostic Testing. The set will be used for activity analysis and will include all randomized subjects with baseline and treatment data. Study staff may visit subjects outside the clinic. Per protocol, the safety analysis sets are described below in Statistical Methods. Peripheral venous blood samples for pharmacokinetic (PK) and immunogenic analysis of DAS181 will be obtained on 10 subjects enrolled in each study arm.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	DAS181 dry powder, formulation F02	10 mg delivered dose DAS181 in clear HPMC #3 Capsules
DRUG	Respitose ML006 (DMV-Fonterra)	Lactose monohydrate

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2009-12-22
• Last updated: 2014-04-08

Locations

42 sites across 1 country: United States